It appears that after several months of decline, Advanced Life Sciences Inc. (OTC:ADLS.OB) appears to be headed in a positive direction.
Recent developments in the Restanza(tm) pipeline are now starting to show their potential and have given investors a peek at their future.
The more recent news follows on the heels of their initial conversations back in March 2010 with the FDA about a Special Protocol Assessment for Restanza(TM) in outpatient community acquired bacterial pneumonia (CABP). They are also hoping to use Restanza for biodefense indications, such as anthrax, plague and tularemia. Additionally, they recently raised $3 million and they entered into a debt for equity exchange with its chairman and CEO Michael T. Flavin for $2 million.
We are really intrigued by the more recent PR’s concerning Restanza and the FDA. More recently(6/30/2010), ADLS submitted a final Special Protocol Assessment (SPA) with the FDA for the proposed Phase III clinical program of Restanza. Michael T. Flavin, Ph.D., Chairman and CEO of Advanced Life Sciences stated, “Based on the FDA's SPA review cycle, we expect a reply to our submission by mid-August of this year.”
Wednesday's news falls in line with the positive direction that ADLS has set out for itself. They have applied for Fast-Track Designation for Restanza(TM), for the treatment of community acquired bacterial pneumonia (CABP). FDA will review the request and make a decision within sixty days based on established criteria. This certainly has a lot of advantages for ADLS shareholders and the Restanza pipeline. Namely:
- More frequent meetings and correspondence with FDA to discuss the drug’s development plan, trial design and ensure collection of appropriate data needed to support drug approval
- Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit,
- Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
Investors should remember that when KERX landed Fast-Track designation for Perifosine back in April, it sent their shares on a 1-2 month bull-run. If ADLS lands Fast-Track Status and a SPA, this would be a big deal for them and would certainly increase their valuation.
At the $0.05 level, we don’t foresee too much downside risk, maybe 10-15%. With several potential news catalysts and developments over the next 1-2 months, ADLS has a bullish rating going forward.
We believe Fast-Track Status and a SPA could push them back to the $0.20-30 levels, since these designations provide a much clearer picture for the approval pathway of Restanza. We look forward to watching Advanced Life Sciences over the next several months.
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